AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
FDA Recall Z-0626-2016 · Posted 2016-01-09
Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodePHX
Date Initiated2015-12-08
Date Terminated2016-03-01
Product Quantity23 units
Reason for Recall
The trial shell mating feature on the broach is undersized.
Firm Action
The recalling firm notified customers of the recall via letter on 12/8/15.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.